Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis

Description

This study evaluates the combined effect of botulinum toxin A (administered as Dysport® (Ipsen Pharmaceuticals)) and bracing in children with adolescent idiopathic scoliosis. Two thirds of patients will be treated with Dysport® and bracing, while the remaining patients will be treated with placebo and bracing.

Conditions

Adolescent Idiopathic Scoliosis

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Study Overview

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Study Details

Study overview

This study evaluates the combined effect of botulinum toxin A (administered as Dysport® (Ipsen Pharmaceuticals)) and bracing in children with adolescent idiopathic scoliosis. Two thirds of patients will be treated with Dysport® and bracing, while the remaining patients will be treated with placebo and bracing.

Dysport ® (abobotulinumtoxinA) as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis

Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis

Condition
Adolescent Idiopathic Scoliosis
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Clinically determined idiopathic nature of scoliosis
  • * Age 10-16 years
  • * Risser stage 0,1,or 2
  • * major curve of 20°-40°
  • * curve apex caudal to T7 vertebra
  • * ability to adhere to bracing protocol
  • * Botulinum toxin naïve or previously treated greater than 6 months prior to study entry
  • * Diagnosis of congenital scoliosis, neuromuscular scoliosis, or other "reason" for scoliosis - Previous surgery at any segment of the spine
  • * Current need for surgery at any level of the spine
  • * Treatment with any drug known to interfere with neuromuscular function
  • * Any other medical condition, laboratory or diagnostic procedure finding that might preclude administration of BTX
  • * Ongoing infection at the injection sites
  • * Diagnosis as either resistant or sensitive to botulinum toxin treatment of any type or to any components of the BTX formulation
  • * Cow milk protein allergy

Ages Eligible for Study

10 Years to 16 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Paul Sponseller, MD, MBA, PRINCIPAL_INVESTIGATOR, Johns Hopkins Hospital Department of Orthopaedic Surgery

Varun Puvanesarajah, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Hospital Department of Orthopaedic Surgery

Study Record Dates

2026-03-31